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| Name | Class |
|---|---|
| Carmel Medical Center | OTHER |
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The purpose of the study is to evaluate the safety of combining phospholipids with medicinal plants for treatment of patients with amyotrophic lateral sclerosis (ALS)
This is an open label pilot study, where patients (n=10) with ALS will take a daily nutritional supplement for 8 months. After documenting the ALS symptom history at baseline, the disease severity, and the motor muscles functions will be assessed at baseline and every two months (0, 2 , 4, 6, 8 months of the treatment). Adverse events and side effect will be assessed on every visit and throughout the experiment. In addition, the level of renal function, liver function and electrolytes will be evaluated from blood samples taken at baseline, 4, and 8 months visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spirit1 | Experimental | Patients will take a daily nutritional supplement for 8 months |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spirit1 | Drug | Spirit 1 is a combination of phospholipids and anti-oxidant medicinal plants |
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| Measure | Description | Time Frame |
|---|---|---|
| Tolerability and safety based on the number and severity of adverse events (AE) | Tolerability and safety evaluations will be based on the documentation of the incidence and severity of short term, and long term side effects, and adverse events (AEs) as well as changes in results of blood tests (increase in levels of liver enzymes, decrease in renal function, changes in complete blood count and electrolytes). | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in score on the ALS Functional Rating Scale Revised (ALS-FRSr) | The ALS-FRS-R is an instrument for evaluating the activities of daily living and global function of patients with ALS. It is used to monitor functional change in a patient over time and includes 12 questions. Each question has 5 possible responses (0-indicates unable to 4-indicates normal ability). Individual item scores are added to produce a reported score of between 0 = worst and 48 = best. A change of ≥25% is considered a clinically meaningful deterioration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacob Meer, MD | Carmel Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hacarmel Hospital | Haifa | Israel |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| 4, 8 months |
| Change from baseline in Forced vital capacity (FVC) | The purpose of this test is to assess the extent of respiratory muscle fatigue. The amount and/or speed (volume and flow respectively) of air that can be inhaled and exhaled will be measured by a commercial spirometer. Vital Capacity is the maximum amount of air a person can expel from the lungs after a maximum inhalation. | 2, 4, 6, 8 months |
| Change from baseline in hand grip power using a dynamometer | The purpose of this test is to measure the maximum isometric strength of the hand and forearm muscles. The subject holds a commercial dynamometer in the hand to be tested, with the arm at right angles and the elbow by the side of the body. When ready the patient will be asked to squeezes the dynamometer with maximum force which is maintained for 3 seconds. This will be repeated 3 times in each hand. The best result from several trials for each hand is recorded, with at least 15 seconds recovery between each effort. | 2, 4, 6, 8 months |
| Change from baseline in walking speed for 10 meters | The purpose of this test is to measure the lower extremities muscle strength. The patients will be asked to walk a distance of 10 meters in their maximal speed. The time to walk this distance will represent the lower extremities muscle strength. | 2, 4, 6, 8 months |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |